Methotrexate Combined With Tofacitinib in the Treatment of Active Rheumatoid Arthritis With a Myeloid-stromal Pathotype a Randomized, Controlled, Open Label, Multicenter Clinical Study

What this Trial Is About

Rheumatoid arthritis RA is a leading cause of disability, especially among Chinese women, and early treatment is crucial to improving outcomes. This research focuses on patients with a specific type of RA called synovial myeloid stromal type, which is linked to more severe disease and poorer response to standard treatment. The study aims to evaluate whether early intensified treatment can improve disease control in these patients by using a new synovial pathology classification to guide therapy. The study compares two treatment approaches for adults with moderate to severe active RA of the synovial myeloid stromal type. One group receives methotrexate combined with tofacitinib, while the other group receives methotrexate alone. Methotrexate is taken orally once a week at doses of 10-15 mg, and tofacitinib is taken orally twice a day at 5 mg. The treatment period lasts 12 weeks, followed by a 48-week follow-up phase. This randomized, open-label study is conducted across multiple centers. Participants will undergo assessments of disease activity, joint function, and safety at various points throughout the study, including weeks 4, 8, 12, 24, 36, and 48. Researchers will measure the proportion of patients achieving at least 20% improvement in RA symptoms at 12 weeks, along with changes in disease activity scores and joint damage progression at 48 weeks. The study also explores serum biomarkers to develop a precise diagnostic system. Overall participation lasts about 60 weeks from treatment start through follow-up.

Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis